MYCHIP study Ver_1.3
Research type
Research Study
Full title
The use and acceptability of a novel technology; Monitoring therapY Compliance in Heart Failure patients usIng electronically tagged Pills (MYCHIP Study)
IRAS ID
158080
Contact name
Martin Cowie
Contact email
Sponsor organisation
Imperial Collge London
Duration of Study in the UK
1 years, 1 months, 4 days
Research summary
Heart failure is common, affecting up to 800 000 people in the UK. Despite effective HF drugs, doctors still find it challenging to treat these patients. One reason is likely due to patients forgetting or not taking their tablets (poor medication compliance).
We are introducing a new system called the Proteus Digital Health Feedback (PDHF) System, which monitors medication compliance. This technology consists of “pills”, tagged with a microchip made of trace elements (Magnesium/Copper) that emit a unique signal when in contact with gastric fluid, which is then picked up by a “patch” (sensor with an on-body sticking plaster) and logs tablet ingestion. It also records physiological variables such as heart rate and activity. These data, using Bluetooth connectivity, is then transmitted on to a tablet device (e.g. an iPad), and then to a central server using a secure data connection, which can then be accessed by patients and physicians. (Further information; http://www.proteus.com).
This PDHF system is CE marked (2010) and has FDA approval (2012). It has previously been used in several studies; management of hypertension, schizophrenia/bi-polar disease, immunosuppressive therapy in post-renal transplant and in anti-tuberculosis (DOT) therapy. There have been no serious adverse events and minor side-effects reported were nausea/vomiting to pills (1%) and skin irritation to the patch (13%). This system has not been previously used in heart failure.
We are carrying out a small proof-of-concept observational study (50 patients) looking at the acceptability and usability of this system for patients with chronic heart failure, using mixed methodology (e.g. focus group interviews, semi-quantitative patient questionnaires and data from PDHF system). We will ask patients to take a Proteus pill each time they take a diuretic tablet, measure daily weights and change patches weekly. Study duration is 12 weeks. There will be no change to the patient’s standard heart failure care.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
15/EM/0102
Date of REC Opinion
20 Feb 2015
REC opinion
Favourable Opinion